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EINSTEIN Junior: Oral Rivaroxaban in Children With Venous Thrombosis (EINSTEIN Jr)

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ClinicalTrials.gov Identifier: NCT02234843
Recruitment Status : Completed
First Posted : September 9, 2014
Last Update Posted : February 25, 2019
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer

Brief Summary:
The purpose of this study is to evaluate comparative efficacy and safety of rivaroxaban to standard of care in children with acute venous thromboembolism.

Condition or disease Intervention/treatment Phase
Venous Thromboembolism Drug: Rivaroxaban (Xarelto, BAY59-7939) Drug: Standard of Care Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 499 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter, Open-label, Active-controlled, Randomized Study to Evaluate the Efficacy and Safety of an age-and Body Weight-adjusted Rivaroxaban Regimen Compared to Standard of Care in Children With Acute Venous Thromboembolism
Actual Study Start Date : November 13, 2014
Actual Primary Completion Date : January 30, 2019
Actual Study Completion Date : January 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban

Arm Intervention/treatment
Experimental: BAY59-7939
Rivaroxaban (tablets and oral suspension) Dose: Age and body weight-adjusted dosing of rivaroxaban to achieve a similar exposure as that observed in adults treated for venous thromboembolism (VTE) with 20 mg rivaroxaban.
Drug: Rivaroxaban (Xarelto, BAY59-7939)
Age and body weight-adjusted dosing equivalent to 20 mg rivaroxaban in adults, once daily or twice daily, as tablets

Drug: Rivaroxaban (Xarelto, BAY59-7939)
Age and body weight-adjusted dosing equivalent to 20 mg rivaroxaban in adults, once daily, twice daily or three times daily, as oral suspension

Experimental: Standard of Care
Subcutaneous low molecular weight heparin (LMWH), subcutaneous fondaparinux and/or oral vitamin K antagonist (VKA) Dose : as per standard of care
Drug: Standard of Care

LMWH (low molecular weight heparin) or fondaparinux or vitamin K antagonist (VKA) therapy.

dose : as per standard of care





Primary Outcome Measures :
  1. Composite number of all symptomatic recurrent venous thromboembolism. [ Time Frame: Up to 12 months ]
    Assessed by a central independent adjudication committee (CIAC)

  2. Composite number of overt major and clinically relevant non-major bleeding. [ Time Frame: Up to 12 months ]
    Assessed by a central independent adjudication committee (CIAC)


Secondary Outcome Measures :
  1. Composite number of all symptomatic recurrent venous thromboembolism and asymptomatic deterioration on repeat imaging. [ Time Frame: Up to 12 months ]
    Assessed by a central independent adjudication committee (CIAC)



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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children aged birth to < 18 years with confirmed venous thromboembolism who receive initial treatment with therapeutic dosages of UFH (unfractionated heparin), LMWH (low molecular weight heparin) or fondaparinux and require anticoagulant therapy for at least 90 days. However, children aged birth to < 2 years with catheter-related thrombosis require anticoagulant therapy for at least 30 days.
  • For children younger than 6 months:

    • Gestational age at birth of at least 37 weeks.
    • Oral feeding/nasogastric/gastric feeding for at least 10 days.
    • Body weight ≥2600 g

Exclusion Criteria:

  • Active bleeding or bleeding risk contraindicating anticoagulant therapy
  • An estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m*2 (in children younger than 1 year, serum creatinine results above 97.5th percentile excludes participation)
  • Hepatic disease which is associated with either: coagulopathy leading to a clinically relevant bleeding risk, or ALT> 5x upper level of normal (ULN) or total bilirubin > 2x ULN with direct bilirubin > 20% of the total
  • Platelet count < 50 x 109/L
  • Sustained uncontrolled hypertension defined as > 95th age percentile
  • Life expectancy < 3 months
  • Concomitant use of strong inhibitors of both cytochrome P450 isoenzyme 3A4 (CYP3A4) and P-glycoprotein (P-gp), including but not limited to all human immunodeficiency virus protease inhibitors and the following azole antimycotics agents: ketoconazole, itraconazole, voriconazole, posaconazole, if used systemically
  • Concomitant use of strong inducers of CYP3A4, including but not limited to rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine
  • Childbearing potential without proper contraceptive measures, pregnancy or breast feeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02234843


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Sponsors and Collaborators
Bayer
Janssen Research & Development, LLC
Investigators
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Study Director: Bayer Study Director Bayer

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02234843     History of Changes
Other Study ID Numbers: 14372
2014-000565-47 ( EudraCT Number )
First Posted: September 9, 2014    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Pediatric
Additional relevant MeSH terms:
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Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants